DescriptionMakrolon 2805 and 2858 polycarbonate resins are linear,medium-viscosity, high-performance thermoplasticsproduced in pellet form for processing primarily byinjection molding. The resins are available in natural,clear tints, and transparent, translucent, and opaquecolors.Makrolon 2805 and 2858 resins contain an internalmold release additive. In addition, Makrolon 2858resin complies with FDA food-contact regulations21 CFR 177.1580 (Polycarbonate Resins) and maybe used in contact with all food types. Most colorsmay be used for all thermal food-contact applications.However, some colors are limited by Conditions of UseB, 21 CFR 175.300 and 176.170 and may not be usedwhen the food is sterilized in the food-contact articleunder autoclaving conditions. Please contact yourBayer Corporation representative with complete detailswhen food contact is involved.Makrolon 2858 resin, in natural 000000 and clear tints550042 and 550115, is also listed under NSF standard51 for use in food equipment. Please consult yourBayer Corporation representative for more informationabout food equipment applications.ApplicationsMakrolon 2805 and 2858 polycarbonate resins have anexcellent balance of engineering properties, includingoutstanding impact strength and ductility, a large servicetemperature range, excellent electrical properties,and dimensional stability. These general purposegrades are used in the automotive industry, buildingand construction, business equipment, consumerproducts, electronics and telecommunications, lighting,packaging, optical devices, optical lenses, and photo-graphic equipment. As with any product, use ofMakrolon 2805 and 2858 resins in a given applicationmust be tested (including but not limited to fieldtesting) in advance by the user to determine suitability.Medical ApplicationsMakrolon 2858 polycarbonate resin is used in a varietyof medical devices.

Biocompatibility:Certain color formulations ofMakrolon 2858 resin, such as clear tint 550115, meetthe requirements of the FDA-modified ISO 10993, Part1 “Biological Evaluation of Medical Devices” testswith human tissue contact time of 30 days or less.Onlyproducts that meet these requirements may be consideredcandidates for applications requiring biocompatibility.Regrind must not be used in medical applicationsrequiring biocompatibility.Manufacturer’s Responsibility: It is the responsibilityof the medical device, biological product orpharmaceutical manufacturer (“Manufacturer”) todetermine the suitability of all component parts andraw materials, including Makrolon 2858 resin, used inits final product in order to ensure safety and compliancewith FDA requirements. This determination mustinclude, as applicable, testing for suitability as animplant device and suitability as to contact with and/orstorage of human tissue and liquids including, withoutlimitation, medication, blood or other bodily fluids.Under no circumstances may Makrolon 2858 resinbe used in any cosmetic, reconstructive or reproductiveimplant applications. Nor may Makrolon 2858 resinbe used in any other bodily implant applications orany applications involving contact with or storage ofhuman tissue, blood, or other bodily fluids for greaterthan 30 days, based on FDA-modified ISO 10993, Part 1“Biological Evaluation of Medical Devices” tests.The suitability of a Bayer product in a given end-useenvironment is dependent upon various conditionsincluding, without limitation, chemical compatibility,temperature, part design, sterilization method, residualstresses, and external loads. It is the responsibility ofthe Manufacturer to evaluate its final product underactual end-use requirements and to adequately adviseand warn purchasers and users thereof.Single-use medical devices made from a Bayer productare not suitable for multiple uses. If the medical deviceis designed for multiple uses, it is the responsibility ofthe Manufacturer to determine the appropriate numberof permissible uses by evaluating the device under actualsterilization and end-use conditions and to adequatelyadvise and warn purchasers and users thereof